NCT05819229 Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
| NCT ID | NCT05819229 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Urinary Tract Infections in Children |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2023-02-27 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2023-02-27 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.
Eligibility Criteria
INCLUSION CRITERIA: 1. Clinical suspicion of urinary tract infection irrespective of the presence of fever. 2. Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal). 3. 4 weeks to 2 months of age (corrected age, if premature). All children who do not receive any empirical antibiotic therapy but have a positive urine culture can be included if the clinical suspicion of urinary tract infection persists. A positive urine culture is defined as: * Suprapubic bladder aspiration: any growth of bacteria. * Sterile intermittent catheterization: monoculture with ≥10\^3 colony forming units per milliliter (cfu/ml). * Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^4 cfu/ml. * Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^5 cfu/ml in one test and 10\^3 cfu/ml in another test. EXCLUSION CRITERIA: 1. Non-Danish civil registration number. 2. High-risk medical history. 1. Previous urinary tract infection. 2. Prophylactic antibiotic treatment. 3. Known urogenital abnormality (i.e., hydronephrosis (pyelectasis ≥10 mm or/and caliectasis ≥5 mm); hydroureter; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; ectopic placed kidneys; polycystic kidney disease; neurogenic bladder dysfunction; and hypospadias). 4. Previous hospitalization needing antibiotic therapy. 3. Markedly elevated c-reactive protein indicating bacteremia. 4. Elevated creatinine. 5. Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).
Contact & Investigator
Naqash Sethi, MD
PRINCIPAL INVESTIGATOR
Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark
Frequently Asked Questions
Who can join the NCT05819229 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, up to 2 Months, studying Urinary Tract Infections in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05819229 currently recruiting?
Yes, NCT05819229 is actively recruiting participants. Contact the research team at naqash.javaid.sethi.02@regionh.dk for enrollment information.
Where is the NCT05819229 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Herlev, Denmark, Hillerød, Denmark, Hvidovre, Denmark.
Who is sponsoring the NCT05819229 clinical trial?
NCT05819229 is sponsored by Rigshospitalet, Denmark. The principal investigator is Naqash Sethi, MD at Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark. The trial plans to enroll 125 participants.